MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient¿s generator had a very short battery life and therefore it is believed to have prematurely depleted.No other relevant information has been received to date.

Event Description

The dhr of the generator was reviewed, and the device passed all functional specifications prior to release.The trim test tab operation was performed during a time in which model 106 generators were not laser-routed.The patient received a generator replacement, stated to be due to battery depletion, and the explanted generator has been received by the manufacturer.Product analysis is underway but has not been completed to date.Multiple attempts for relevant information were made, but no information has been received to date.No other relevant information has been received to date.

Event Description

The patient's generator was returned and underwent product analysis (pa).The reported allegation of premature end of life (eol) was not duplicated in the pa lab.Both interrogation and system diagnostic tests were performed and were as expected for the programming parameters.A visual assessment on the pcba showed no contaminates on the trimmed edge of the pcba.The battery was removed and a postburn electrical test was performed in which the generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No further information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7776398
• MDR Text Key: 116871037
• Report Number: 1644487-2018-01382
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: 106
• Device Lot Number: 203359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR